Platform for Clinical Trials in Nutrition and Health

NCT04067921 | Active Not Recruiting

• 1 other identifier: CEI 27-666
• Study Type: observational
• Target: 1,963
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the known link between dietary patterns and disease, it has been observed that the specific response of each individual to dietary components highly varied, and this may limit the impact of the nutritional interventions to improve public health. These observations provided the basis to the development of the Nutritional Genomics at the beginning of the 90s, which main goal was to study the interaction between dietary factors and the genome that modulate phenotypic expression. From this idea, in the recent years, Precision Nutrition has been emerged as a therapeutic approach that takes into account all individual's characteristics to develop targeted nutritional advices. The main goal of Precision Nutrition is to maintain or improve health by using genetics, phenotypic, clinical, dietary and other information to provide more precise and more efficacious personalized healthy eating advice and to motivate appropriate dietary changes. However, all the genotype-dependent advice must be based on scientific evidence. Most of the available evidence in support of personalized nutrition has come from observational studies with risk factors as outcomes, and it was needed randomized controlled trials using clinical endpoints to ratify these results. The main objective of the Platform for Clinical Trials in Nutrition and Health (GENYAL) is to contribute to Precision Nutrition Research by the construction, for the first time, of a human gene and phenotype database to be used in: 1) The evaluation of the efficacy of different foods, functional foods and bioactive compounds capsules on general population and by genotypes and 2) The performance of nutritional genetics and nutrigenomics studies. For that purposes, GENYAL has a permanent recruitment of volunteers, which are phenotypically and genotypically characterized, and give consent to be contacted to perform clinical trials and nutritional intervention studies. Therefore, GENYAL may help to increase the existing knowledge for moving along to Nutritional Genomics research to its practical application in Precision Nutrition; contributing in the improvement in health and disease prevention through dietary recommendations based on the genome.

Conditions

Healthy Volunteers

Keywords

Precision Nutrition; Nutritional Genetics; Nutritional Genomics; Polymorphisms

Outcome Measures

Primary Outcomes (1)

• Genotypic characterization.

  Genomic DNA is isolated from a blood sample. Genotyping was performed using the QuantStudio 12 K Flex Real-Time PCR System (Life Technologies Inc., Carlsbad, CA) with a TaqMan OpenArray plates.

  Baseline.

Secondary Outcomes (21)

• Changes in total daily energy intake (TEI).

  At the beginning and before 12 months.

• Changes in macronutrients intake.

  At the beginning and before 12 months.

• Changes in fatty acids intake.

  At the beginning and before 12 months.

• Changes in cholesterol intake.

  At the beginning and before 12 months.

• Changes in fiber intake.

  At the beginning and before 12 months.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Free-living adults aged from 18 to 70 years and residents of Spain.

You may qualify if:

• Free-living adults aged from 18 to 70 years that give written informed consent to be contacted to perform clinical trials and nutritional intervention studies.

You may not qualify if:

• Suffering from any serious illness (kidney or liver diseases or other condition that affects lifestyle or diet).
• Presenting dementia or impaired cognitive function
• Being pregnant or breastfeeding.

Sponsors & Collaborators

• IMDEA Food: lead

Study Sites (1)

IMDEA Food

Madrid, 28049, Spain

Location

Related Publications (1)

• Camblor Murube M, Borregon-Rivilla E, Colmenarejo G, Aguilar-Aguilar E, Martinez JA, Ramirez De Molina A, Reglero G, Loria-Kohen V. Polymorphism of CLOCK Gene rs3749474 as a Modulator of the Circadian Evening Carbohydrate Intake Impact on Nutritional Status in an Adult Sample. Nutrients. 2020 Apr 19;12(4):1142. doi: 10.3390/nu12041142.

  PMID: 32325849 DERIVED

Study Officials

• Ana Ramírez, PhD

  IMDEA Food

  STUDY DIRECTOR

• Guillermo Reglero, Prof. PhD

  IMDEA Food

  STUDY DIRECTOR

• Viviana Loria-Kohen, PhD

  IMDEA Food

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 28, 2019
• Study Start: November 11, 2011
• Primary Completion: March 28, 2022
• Study Completion: March 28, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-02

Locations

ES (1)